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Detection of Choroidal Nevus Cells in Vitrectomy Fluid

This study has been terminated.
(Could not recruit enough patients)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01324609
First received: March 25, 2011
Last updated: March 22, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to determine if the investigators can detect the presence of choroidal nevi cells in the vitreous fluid of humans, as this may improve the diagnosis and classification of choroidal nevi and melanomas in the future.


Condition
Nevus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Choroidal Nevus Cells in Vitrectomy Fluid

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Moles
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Positive identification of nevus cells in eye fluid [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: June 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Approximately 7% of the population has a choroidal nevus, or "freckle," in the back of the eye. Like a nevus on the skin, there is potential for malignant change to a melanoma. Dermatologists have the ability to quickly and easily biopsy suspicious skin lesions while ophthalmologists currently have no way of determining the malignant potential of choroidal nevi other than a fine needle aspiration (which is invasive and has the potential complications of bleeding and retinal detachment). This study's sole aim is to see if choroidal nevi cells are present in the inside fluid of the eye. The investigators plan to analyze the fluid of the eye, which is routinely removed during retina surgery, to detect any nevus cells. If the investigators are able to detect these cells, then future studies may allow us to better classify choroidal nevi for potential malignant change.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication.

Criteria

Inclusion Criteria:

  • Patients with a choroidal nevus who are undergoing routine vitrectomy surgery for another indication (such as epiretinal membrane or macular hole repair).

Exclusion Criteria:

  • Patients without a choroidal nevus
  • Children under the age of 18
  • Pregnant and nursing females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01324609

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr. Darius M. Moshfeghi Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01324609     History of Changes
Other Study ID Numbers: SU-03242011-7564, IRB-18580
Study First Received: March 25, 2011
Last Updated: March 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
choroidal nevus
vitrectomy

Additional relevant MeSH terms:
Nevus
Nevus, Pigmented
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013